What is the Difference Between Phase 3 and 4 Trials?
Clinical research is crucial to the development of treatments and medications as we know them today. In order for a medical treatment to be approved for use by the public, it must go through four phases of clinical trials in order to determine its efficacy and safety, and whether it affects everyone the same way.
Phase 1 is when a treatment is tested for the first time. This phase is generally done with a small group of volunteers. It primarily assesses safety and side effects of the treatment in question.
During Phase 2, the treatment is tested with a larger group of volunteers. This assesses its effectiveness and further evaluate its safety.
Phase 3 compares the new treatment to existing treatments. This is done with an even larger group of volunteers, and generally for a longer period of time. As a result, rare and/or long-term side effects are more likely to be discovered. Phase 3 is the final phase before a treatment receives FDA approval.
Following FDA approval, a treatment goes through Phase 4. This phase involves the largest group of participants. It can last for several years as researchers continue to monitor the efficacy and safety of the treatment.
Depending on the type of treatment being studied, a study could range from several weeks to several years; volunteers may or may not participate in every phase of the study. If you are considering volunteering for a clinical trial, make sure you know which phase the study is currently in. Also, understand the duration of your participation.